Expectant or active management in women with severe preeclampsia at 28-34 weeks

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2011
INTERVENTION: After admission for severe preeclampsia, patients will be stabilised with antihypertensive medication and magnesium sulphate and administered corticosteroids for inducement of fetal maturity according to standard practice. After 24 hours, patients, who did not develop a major maternal complication or a fetal indication for delivery, will be randomised for either termination of pregnancy 48 hours after admission or for expectant management. CONDITION: ; Pre‐eclampsia ; ; PRIMARY OUTCOME: The primary outcome is composite major neonatal morbidity and perinatal mortality. ; ; SECONDARY OUTCOME: The secondary long‐term neonatal outcome is a Bailey‐3 assessment at two years corrected age. ; The secondary short‐term maternal outcome is the occurrence of major complications before and after delivery. The secondary long‐term maternal outcome is persistent morbidity or death. INCLUSION CRITERIA: 1. Informed consent; 2. Working knowledge of Dutch language; 3. Gestational age 27.6 – 33.5 weeks at inclusion; 4. Estimated fetal weight = 500 gram at inclusion; 5. No major fetal congenital anomalies; 6. Severe preeclampsia (modified from the criteria for severe preeclampsia (ACOG practice bulletin no. 33, table 1)): Preeclampsia (hypertension with proteinuria = 0.3 g/24 hrs) and one or more of the following criteria: A. Clinical symptoms like cerebral or visual disturbances (e.g. headache) and/or right upper quadrant or epigastric pain; B. Laboratory abnormalities: thrombocytopenia (< 100 x 109/L) and/or impaired liver function tests (ASAT/ALAT = 70 U/L and lactic dehydrogenase (LDH) = 600 U/L) and/or haptoglobin < 0.2 g/L; C. Severe hypertension with intravenous antihypertensive medication (systolic =160 mmHg and/or diastolic =110 mmHg).
Epistemonikos ID: 309376f5a4ce183b7a99cd1b2495d6fd5101717b
First added on: Aug 22, 2024